UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003799
Receipt number R000004593
Scientific Title Effect of recombinant thrombomodulin (ART123) for sepsis with disseminated intravascular coagulation
Date of disclosure of the study information 2010/07/01
Last modified on 2017/05/03 09:23:59

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Basic information

Public title

Effect of recombinant thrombomodulin (ART123) for sepsis with disseminated intravascular coagulation

Acronym

Effect of rTM for sepsis with DIC

Scientific Title

Effect of recombinant thrombomodulin (ART123) for sepsis with disseminated intravascular coagulation

Scientific Title:Acronym

Effect of rTM for sepsis with DIC

Region

Japan


Condition

Condition

severe sepsis, septic shock, sepsis with disseminated intravascular coagulation

Classification by specialty

Infectious disease Emergency medicine Intensive care medicine
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Previous studies showed that recombinant thrombomodulin(rTM) may improve the outcome of sepsis induced multiple organ failure because of its anticoagulant and anti-inflammatory properties. We have performed a randomized controlled trial to assess whether rTM has the effect for sepsis induced multiple organ failure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

28-day mortality
hemorrhagic event

Key secondary outcomes

28-day ICU mortality
SOFA score
data of coagulation (platelet, PT-INR, fibrinogen, FDP, TAT, PIC, ATIII, protein C, protein S)
data of inflammation (CRP, procalcitonin, IL-1beta, IL-6, TNF-alfa, HMGB1)
resolution rate of JAAM DIC score
weaning rate of mechanical ventilator


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

administration of recombinant thrombomodulin

Interventions/Control_2

administration of saline

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

svere sepsis and septic shock with acute DIC score more than 4 points

Key exclusion criteria

hemorrhagic complication
pregnant

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiro OTOMO

Organization

Tokyo Medical and Dental University Medical Hospital

Division name

Shock, Trauma, and Critical Care Center

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5102

Email

otomo.accm@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiki SERA

Organization

Tokyo Medical and Dental University Medical Hospital

Division name

Shock, Trauma, and Critical Care Center

Zip code


Address

1-5-45Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5102

Homepage URL

http://www.tmd.ac.jp/med/accm/

Email

seraaccm@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University Medical Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東京医科歯科大学医学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2010 Year 07 Month 01 Day


Related information

URL releasing protocol

http://www.tmd.ac.jp/med/accm/

Publication of results

Partially published


Result

URL related to results and publications

http://www.tmd.ac.jp/med/accm/

Number of participants that the trial has enrolled


Results

As of December 30, 2014, there were 27 cases for intervention group and 28 cases for placebo group.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2008 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information

One adverse event occurred among intervention group.


Management information

Registered date

2010 Year 06 Month 22 Day

Last modified on

2017 Year 05 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004593


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name